FDA approves first OTC test for chlamydia and gonorrhea

FDA granted marketing approval to the first diagnostic test for chlamydia and gonorrhea with at-home sample collection.

Called the Simple 2 Test from LetsGetChecked, the test will be available OTC and is intended for use in individuals 18 years and older.

The Simple 2 Test is the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV. The only cleared tests for either chlamydia or gonorrhea have required samples collected at the point of care, such as a doctor’s office.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in a news release. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

With the new test, samples are collected at home using either vaginal swabs or urine specimens, as appropriate, and are then submitted to a designated laboratory for testing. Results are provided online, with follow up from a health care provider in cases of positive or invalid test results.